ES3043107T3 - A surgical device - Google Patents

Abstract

A surgical device for arthroscopy (1) comprising: - an insertion arm (2) with a folded contact end (4) configured to support the surgical device (1) against the patient's bone (T); - a handle (3) connected to a connecting end (2a) of the insertion arm (2), opposite the folded contact end (4), and extending transversely to the insertion arm (2); and - a retrieval element (11) connected to the insertion arm (2) and movable along it between a retracted position and an extended position, where it intercepts the leading end of a suture thread (S) at the folded contact end (4), and movable between the extended position and the retracted position, where it grasps the leading end. The retrieval element (11) is a basket of flexible material defining a containment volume suitable for receiving said leading end of the suture thread (S). The containment volume is configured to expand during the transition between the retracted and extended positions, and to contract during the transition between the extended and retracted positions. (Automatic translation using Google Translate, not legally binding)

Description

[0001] DESCRIPTION

[0002] A surgical device

[0003] Field of invention

[0004] The invention relates to a surgical device, in particular a surgical device for arthroscopy.

[0005] The invention finds particular application in the field of orthopedic surgery.

[0006] Previous technique

[0007] The following description will refer, by way of example, to a surgical device for posterior cruciate ligament reconstruction operations of the knee in arthroscopy, without loss of the generality of the invention.

[0008] This type of surgery generally involves the construction of a tibial tunnel and a femoral tunnel, angled relative to each other, in the knee joint, into which a replacement ligament, also known as a graft, is passed.

[0009] Document US 4,739,751 shows an example of a surgical apparatus for this field.

[0010] The graft is typically inserted from the front entrance of the tibial tunnel, made in the front of the tibia, until it emerges into the tibial plate and is then twisted around the intercondylar fossa of the femur ("killer twist") and finally inserted into the femoral tunnel.

[0011] To insert the graft into the tibial tunnel, a suture thread, to which the graft is attached at the tail end, must be passed through the tunnel so that, by pulling the head of the suture thread past the tunnel exit, the graft can be dragged into the tunnel through the entry section.

[0012] To insert the suture thread into the tibial tunnel, forceps or a curved suture loop can be used, which is guided along a predetermined insertion direction that usually coincides with the drilling axis of the tibial tunnel, until the suture thread head is positioned beyond the tunnel exit.

[0013] When the leading end of the suture thread emerges from the exit section of the tibial tunnel, in the tibial plate, the surgeon should grasp this end with another tool (e.g., forceps) to pull it forward from the knee through the anteromedial portal and thus pull the graft into the tibial tunnel.

[0014] The applicant noted that the operation of grasping the front end of the suture thread, when operating in arthroscopy, is not simple, but in fact is particularly uncomfortable and dangerous.

[0015] In fact, the applicant found that the surgeon, by not clearly seeing where to grasp the leading end of the suture thread during the insertion of the forceps to reach the free end of the thread at the tibial tunnel exit, risked damaging the tibial plate, meniscus, and blood vessels. Operating with poor visibility, performing arthroscopic posterior cruciate ligament reconstruction of the knee is very complicated and therefore requires in-depth knowledge, experience, and precision in handling surgical instruments.

[0016] Purpose of the invention

[0017] In this context, the technical task underlying this invention is to propose a surgical device for arthroscopy that overcomes one or more of the aforementioned drawbacks of the prior art.

[0018] In particular, the purpose of this invention is to provide a surgical device for arthroscopy that will improve the surgeon's operating experience by increasing the level of accuracy and safety of the surgical steps involved in the reconstruction of the ligaments of a knee joint.

[0019] In particular, the purpose of this invention is to provide a surgical device for arthroscopy that enables the surgeon to efficiently and effectively grasp the leading end of a suture thread inserted into a patient's tibial tunnel in a simple and precise manner in order to preserve the surrounding neurovascular structures.

[0020] An additional purpose of this invention is to propose a retrieval group that enables the surgeon to efficiently and effectively retrieve the leading end of a suture thread and that can be easily implemented in existing surgical devices for arthroscopy.

[0021] The specified technical task and purposes are basically achieved with a surgical device for arthroscopy comprising the technical features set forth in one or more of the appended claims.

[0022] In particular, this invention provides a surgical device for arthroscopy comprising an insertion arm and a handle.

[0023] The insertion arm has a folded contact end, configured to support the surgical device against the patient's bone.

[0024] The handle is connected to a connecting end of the insertion arm, opposite the folded contact end, and extends transversely to the insertion arm.

[0025] Advantageously, the surgical device also comprises a retrieval element for retrieving the front end of a suture thread connected to the insertion arm.

[0026] The retrieval element is movable along the insertion arm between a retracted position and an extended position in which it intercepts the front end of the suture thread at the folded contact end.

[0027] Advantageously, the recovery element is also movable between the extended and retracted positions in which it holds said front end.

[0028] Thanks to the retrieval element, the surgical device allows for the easy and precise interception and grasping of the leading end of the suture thread, which is placed at the contact end in contact with the patient's bone. In surgical reconstruction of the posterior cruciate ligament of the knee, the folded contact end of the insertion arm is configured to rest on the posterior aspect of the tibia, where the tibial tunnel opens, and, according to this invention, the retrieval element allows for the practical and precise interception (in the retracted position) of the leading end of the suture thread placed at the exit section of the tibial tunnel and for grasping it after it has been switched to the retracted position.

[0029] In this way, the surgeon can simply proceed to extract the joint insertion arm through the anteromedial portal to pull the suture thread, and thus the graft attached to it, into the tibial tunnel. Advantageously, by supporting the surgical device against the tibial tunnel exit, it is possible to directly grasp the leading end of the suture thread simply by changing the retrieval element between the extracted and retracted positions, without the need for additional instruments and with the accuracy provided by the initial positioning of the surgical device.

[0030] The surgical device is, in fact, typically an awl ("aimer") used from the preliminary steps of the operation to create the tibial tunnel. Therefore, with the same surgical device used to aim and drill the tibial tunnel, it is possible to precisely insert the suture thread that carries the graft.

[0031] In fact, by removing the insertion arm from the contact position of the tibia and pulling it outwards from the knee, it is possible to pull the front end of the suture thread retrieved and intercepted at the exit of the tibial canal and retained by the retrieval element to pull the graft into the tunnel in a simple, precise and safe manner.

[0032] Advantageously, the retrieval element is a basket made of flexible material that defines a containment volume suitable for receiving the leading end of the suture thread.

[0033] In particular, the containment volume is configured to expand at the transition between the retracted and extended positions and to narrow at the transition between the extended and retracted positions.

[0034] The dependent claims, included in this document by reference, correspond to different embodiments of the invention.

[0035] Brief description of the drawings

[0036] Additional features and advantages of this invention will become clearer from the indicative, and therefore non-limiting, description of a preferred, but not exclusive, embodiment of a surgical device for arthroscopy, as illustrated in the accompanying drawings, in which:

[0038] - Figure 1 is a schematic perspective view of a surgical device for arthroscopy according to this invention during a step of use in which it is supported against the bone of a patient,

[0039] - Figure 2 is a schematic perspective view of the device in Figure 1, wherein the retrieval element is in the extended position,

[0040] - Figure 2A is an enlarged view of a detail from Figure 2,

[0041] - Figure 3 is a schematic perspective view of the device in Figure 1, wherein the recovery element is in the retracted position,

[0042] - Figure 3A is an enlarged view of a detail from Figure 3 and

[0043] - Figures 4 and 5 are schematic perspective views of a recovery group according to this invention, wherein the recovery element is in the extended and retracted positions, respectively.

[0045] Detailed description of preferred embodiments of the invention

[0047] With reference to the accompanying figures, reference number 1 indicates, as a whole, a surgical device for arthroscopy according to the present invention, hereinafter simply referred to as Device 1.

[0049] Device 1 comprises an insertion arm 2 and a handle 3.

[0051] The insertion arm 2 and handle 3 preferably define a so-called surgical pointer.

[0053] The insertion arm 2 has a folded contact end 4, configured to support the device 1 against a patient's T-bone.

[0055] In particular, Figure 1 illustrates a portion of a patient's knee joint, in which bone T is a tibia and folded contact end 4 is configured to rest on the rear area under the tibial plate where the unillustrated exit section of the tibial tunnel C will be created.

[0057] The folded contact end 4 is preferably curved to prevent sharp edges from causing injury during insertion.

[0059] While using device 1, the insertion arm 2 can be partially inserted into the patient's knee, while the handle 3, which extends below the arm, remains outside the knee to be grasped by the surgeon. Specifically, the insertion arm 2 is inserted anteriorly, through the intercondylar portal defined between the tibia T and the femur F, and into the posterior area of the tibial plate.

[0061] Handle 3 is connected to a connecting end 2a of the insertion arm 2, opposite the folded contact end 4 and extends transversely to the insertion arm 2.

[0063] A pointer is used to perform, according to known operating techniques, the tibial tunnel C, illustrated in Figure 1, by drilling through the tibia T along a straight path.

[0065] The pointer is preferably defined by at least the insertion arm 2 and the handle 3.

[0067] A projecting portion 3a of handle 3 preferably has a coupling eyelet 5 extending around a longitudinal axis X directly toward the folded contact end 4.

[0069] The coupling eyelet 5 is configured to slide a guide element 6 of a suture thread S inside; the guide element 6 is illustrated schematically as a pair of clamps in Figure 2, movable along a straight guide path P coincident with the longitudinal axis X to position a front end of the suture thread S at the folded contact end 4.

[0071] In other words, the guide element 6 is a tool that has a shape suitable for being inserted into the coupling eyelet 5 and the tibial tunnel C to bring the leading end of the suture thread S to the terminal contact end 4 of the insertion arm 2 when the pointer is disposed in contact with the tibia T.

[0072] The protruding portion 3a is preferably separable and can be rotated to adjust the insertion angle, i.e., the orientation of the longitudinal X axis.

[0074] Advantageously, device 1 comprises a retrieval element 11 connected and movable along the insertion arm 2 between a retracted position and an extended position.

[0076] In particular, in the extended position, it intercepts the leading end of the suture thread S at the folded contact end 4 (Figure 2), while in the retracted position it grasps the leading end of the suture thread S (Figure 3). In particular, the retrieval element 11 is fixed to the insertion arm 2 to move only between the two operative positions just described, so that the surgeon can quickly intercept the thread S in the extended position and hold it in the retracted position, without the need for any other tools.

[0078] Once the thread S is held in a retracted position, the surgeon is able to simply remove the patient's insertion arm 2 in order to extract the suture thread S, to which a ligament replacement graft has been conveniently attached at its end, so that the graft, not illustrated, can be pulled into the tibial tunnel C to reconstruct the ligament.

[0080] Thanks to the use of recovery element 11, it is therefore possible to significantly reduce intervention times, being of immediate use, and to increase operational efficiency, with the grip of the suture thread S being precise and secure.

[0081] In addition, recovery element 11 reduces the risks associated with possible injuries to the posterior areas of the knee, as it minimizes the number of surgical devices that need to be inserted and removed from the patient's knee.

[0083] With reference to the embodiment illustrated in the accompanying figures, the retrieval element 11 is a basket made of flexible material, preferably Nitinol, which defines a containment volume suitable for receiving the front end of the suture thread S.

[0085] In particular, the containment volume is configured to expand at the transition between the retracted and extended positions and to narrow at the transition between the extended and retracted positions.

[0087] As can be clearly seen in Figure 2A, in other words the basket is a cage defined by a plurality of threads 11a spaced apart from each other by interstices 11b. In particular, the interstices 11 are of the appropriate size to allow the passage of the suture thread S.

[0089] Advantageously, the basket makes it possible to have a 360° gripping zone to effectively hold the S thread, limiting the maneuvers that the surgeon must perform to intercept it.

[0091] Advantageously, the basket can be manufactured with customized configurations based on the surgeon's needs.

[0092] The choice of basket shape may also depend on the space available for opening and movement in the area behind the knee.

[0093] The narrowing of the basket volume at the transition between the extended and retracted positions ensures an effective grip on the front end of thread S, which could not be obtained as efficiently by inserting a pair of tweezers.

[0094] Furthermore, device 1 preferably comprises a containment channel 12 for the recovery element 11 extending along the insertion arm 2 and having an outlet section 12a leading to the folded contact end 4 of the insertion arm 2 and an inlet section 12b located at the connection end 2a.

[0096] Advantageously, the containment channel 12 performs a dual function of guiding and protecting the recovery element 11.

[0098] The recovery element 11 is preferably arranged completely within the containment channel 12 in the retracted position (Fig. 3A) and emerges at least partially beyond the outlet section 12a of the containment channel 12 in the extended position (Fig. 2A).

[0100] Advantageously, Nitinol is a shape memory material, so that when the Nitinol basket is in the retracted position it is deformable and can be squashed and placed in the containment channel 12 assuming a compact linear shape, while when it is ejected to be disposed in the extracted configuration it expands and assumes the shape of the basket.

[0102] As can be seen in the attached figures, the containment channel 12 is preferably arranged along a predominant part of the extension of the insertion arm 2.

[0104] Furthermore, the containment channel 12 preferably extends at least partially along an upper surface 13a of the insertion arm 2. In particular, the insertion arm 2 has a groove 14 for the passage of the containment channel 12 from the upper surface 13a to a lower surface 13b of the insertion arm 2.

[0106] It should be noted that, "lower surface" 13b refers to the surface facing handle 3, while the upper surface 13a refers to the opposite surface, which does not face handle 3.

[0108] The device 1 according to this invention preferably further comprises a retrieval element 11 switch 15 configured to switch the retrieval element 11 between a non-operational configuration, in which the retrieval element 11 is in a retracted position and does not intercept the leading end of the suture thread S, and a semi-operational configuration, in which the retrieval element 11 is in a retracted position and can intercept the leading end (Figures 2 and 2A), and between the semi-operational configuration and an operational configuration, in which the retrieval element 11 is in the retracted position and grasps the leading end of the thread S (Figures 3 and 3A).

[0109] In particular, in the operating configuration, the basket and the thread S create a knot N (Fig. 3A) that makes them solid together, allowing an efficient extraction movement of the thread S from the operated knee by the surgeon.

[0111] Switch 15 is preferably arranged at the connection end 2a of the insertion arm 2, close to handle 3. Advantageously, therefore, switch 15 is arranged in a convenient position and can be easily maneuvered by the surgeon's thumb.

[0112] The switch 15 preferably comprises a slider 16 configured to move the recovery element 11 along the insertion arm 2 away from or towards the folded contact end 4.

[0113] The retrieval element 11 can preferably be extracted from the containment channel 12 along a section SL of a predetermined length, so as to allow controlled retrieval of the suture thread S, reducing the risk of damaging the neurovascular structure of the surrounding tissue.

[0114] For the surgeon, a fixed value of the SL section ensures that the recovery element 11 does not project more than necessary towards the back of the knee.

[0115] With reference to Figure 2, section SL thus advantageously represents the excursion of the recovery element 11 beyond the outlet section 12a of the containment channel 12.

[0116] With reference to the embodiment illustrated in the accompanying figures, slider 16 is, in fact, a sliding block that slides along a section SL.

[0117] According to a further embodiment not illustrated in the accompanying figures, the slider 16 can be a wheel configured to rotate around an arc of a circle equal to the SL section.

[0118] The device 1 according to the present invention may further comprise a spring, not illustrated in the accompanying figures, connected to the switch 15 and configured to maintain the return element 11 in the retracted position. Advantageously, in this way, it would be possible to avoid accidentally activating the change between one configuration and another. The spring is preferably arranged within the insertion arm 2 or the containment channel 12, or, again, between the switch 16 and the return element 11.

[0119] With reference to Figures 2A and 3A, the folded contact end 4 preferably has a head portion 4a comprising a groove 19 arranged along the longitudinal axis X of the coupling eyelet 5, against which the guide element 6 can rest.

[0120] Advantageously, slot 19 basically defines an end stop of the guide travel P that prevents excessive advancement of the guide element 6 inside the tibial tunnel C.

[0121] In addition, the head portion 4a preferably has protruding side edges 17 that define a widening of the head portion 4a around the groove 19.

[0122] The term "widening" refers, in particular, to the width of the head portion 4a measured along the lower surface 13b of the insertion arm 2 in the direction perpendicular to the extension direction of the insertion arm 2.

[0123] Advantageously, the protruding lateral edges 17 make it possible to reduce the risk of damaging the surrounding structures in the event of an off-center insertion of the guide element 6 inside the tibial tunnel C.

[0124] In other words, the protruding lateral edges 17 define additional lateral protection in case the guide element 6 is inserted too deeply into the tibial tunnel C and contacts the folded contact end 4 in an off-center position relative to the groove 19.

[0125] The folded contact end 4 further comprises at least one contact tooth 18 configured to rest against bone T.

[0126] Even more preferably, in the illustrated embodiment, it comprises two contact teeth 18 arranged in the head portion 4a.

[0127] Furthermore, the transition groove 14 of the containment channel 12 is preferably arranged above and close to the groove 19 so that during the tibial drilling step T, where the retrieval element 11 is in the retracted position, the retrieval element 11 is protected and out of the guide path P, whereas in the extracted position it can occupy the volume where the leading end of the suture thread S is carried.

[0128] Advantageously, the containment channel 12 follows the curve of the insertion arm 2 until it opens into the groove 19. According to a further aspect of this invention, a retrieval group 10 is provided for the arthroscopic surgical device, comprising:

[0129] - a recovery item 11 as described above,

[0130] - a 15 switch as described above, and

[0131] - at least one fastening element 20, for example a clip, configured to reversibly connect the retrieval group 10 to an insertion arm 2 of a pointer. The retrieval group 10 according to this invention is configured as a disposable mechanism that can be attached to a pointer before it is inserted into the knee joint by the surgeon. Thanks to the presence of the fastening elements 20, it is possible to conveniently attach a sterile retrieval group 10 to a pre-existing pointer and remove it at the end of the operation.

[0132] Figures 4 and 5 schematically illustrate a preferred embodiment of recovery group 10 according to this invention.

[0133] In particular, before the start of the operation and therefore before inserting the pointer into the patient's knee, the surgeon can conveniently attach the clips 20 to the upper surface 13a of the insertion arm 2 and insert the end portion of the containment channel 12 into the groove 14 so that the outlet section 12a is disposed at the folded contact end 4.

[0134] This invention thus achieves the proposed aims, overcoming the drawbacks of the reported prior art and providing the user with an effective surgical device 1 which, thanks to the presence of the recovery element 11, allows the surgeon to operate with precision and speed, and in a minimally invasive manner.

[0135] In particular, this invention provides a single device 1 that is capable of both perforating the tibia T to create the tibial tunnel C and passing the suture thread S around the tibial plate to insert the graft into the tibial tunnel C. Advantageously, and furthermore, the retrieval group 10 comprising the retrieval element 11 can be one-piece with the device 1 or define a separate element that can be reversibly attached to a pointer to conveniently modernize existing surgical devices.

Claims (15)

1. CLAIMS 1. A surgical device for arthroscopy (1) comprising: - an insertion arm (2) having a folded contact end (4), configured to support the surgical device (1) against a bone (T) of a patient; - a handle (3) connected to a connection end (2a) of the insertion arm (2), opposite said folded contact end (4) and extending transversely to said insertion arm (2); - a retrieval element (11) connected to said insertion arm (2) and movable along said insertion arm (2) between a retracted position and an extended position in which it intercepts a front end of a suture thread (S) at said folded contact end (4), and movable between said extended position and said retracted position in which it grasps said front end; characterized in that said retrieval element (11) is a basket of flexible material that defines a containment volume suitable for receiving said front end of the suture thread (S), said containment volume being configured to expand in the transition between the retracted and extracted positions and to contract in the transition between the extracted and retracted positions. 2. The surgical device for arthroscopy (1) according to claim 1, wherein said basket is made of Nitinol. 3. The surgical device for arthroscopy (1) according to claim 1 or 2, comprising a containment channel (12) of the retrieval element (11) extending along the insertion arm (2) and having an outlet section (12a) leading to said folded contact end (4) of the insertion arm (2) and an inlet section (12b) located at the connecting end (2a). 4. The surgical device for arthroscopy (1) according to claim 3, wherein the retrieval element (11) is located completely within the containment channel (12) in the retracted position and emerges at least partially beyond the exit section (12a) of said containment channel (12) in the extended position. 5. The surgical device for arthroscopy (1) according to claim 3 or 4, wherein the containment channel (12) extends at least partially along an upper surface (13a) of the insertion arm (2); said insertion arm (2) having a groove (14) for the passage of the containment channel (12) from the upper surface (13a) to a lower surface (13b) of the insertion arm (2). 6. The surgical device for arthroscopy (1) according to one or more of the preceding claims, comprising a switch (15) for the retrieval element (11) configured to switch the retrieval element (11) between a non-operative configuration, in which the retrieval element (11) is in the retracted position and does not intercept the leading end of the suture thread (S), and a semi-operative configuration, in which the retrieval element (11) is in the extended position and can intercept said leading end, and between the semi-operational configuration and an operational configuration, wherein the recovery element (11) is in the retracted position and holds said front end. 7. The surgical device for arthroscopy (1) according to claim 6, wherein the switch (15) is located at the connection end (2a) of the insertion arm (2), near the handle (3). 8. The surgical device for arthroscopy (1) according to claim 6 or 7, wherein the switch (15) comprises a slider (16) configured to move the retrieval element (11) along the insertion arm (2) away from or towards the folded contact end (4). 9. The surgical device for arthroscopy (1) according to claim 8, wherein the slider (16) is a sliding block. 10. The surgical device for arthroscopy (1) according to claim 8, wherein the slider (16) is a wheel. 11. The surgical device for arthroscopy (1) according to one or more of claims 6-10, comprising a spring connected to the switch (15) and configured to maintain the retrieval element (11) in the retracted position. 12. The surgical device for arthroscopy (1) according to one or more of the preceding claims, wherein a projecting portion (3a) of the handle (3) has a coupling eyelet (5) extending about a longitudinal axis (X) directed towards the folded contact end (4), said coupling eyelet (5) being configured to slideably receive inside it a guide element (6) for the suture thread (S), which is movable along a straight guide path (P) coinciding with said longitudinal axis (X), so that it has its front end at said folded contact end (4). 13. The surgical device for arthroscopy (1) according to claim 12, wherein the folded contact end (4) has a head portion (4a) comprising a groove (19) arranged along the longitudinal axis (X) of the coupling eyelet (5), against which the guide element (6) can rest. 14. The surgical device for arthroscopy (1) according to claim 13, wherein the head portion (4a) of the folded contact end (4) has protruding lateral edges (17) that define a widening of said head portion (4a) around the groove (19). 15. The surgical device for arthroscopy (1) according to one or more of the preceding claims, wherein the folded contact end (4) comprises at least one contact tooth (18) configured to rest against the bone (T).